Scientists at the Fred Hutchinson Cancer Research Center (FHCRC) have established a strong clinical research program in hematopoietic stem cell transplantation and have developed novel approaches for the treatment of malignancies and infectious diseases. Many of these unique strategies incorporate cellular therapy, where specific ex-vivo manipulated stem cell or T cell populations are infused into patients as part of the overall treatment. Several trails are now ongoing at FHCRC involving stem cell expansion, gene therapy, T cell activation, and adoptive immunotherapy for the treatment of infectious diseases caused by CMV and HIV, and malignancies including leukemia, lymphoma, and melanoma. For example, in selected studies T cell clones with the desired antigen specifically must be identified, isolated, in some situations genetically altered, grown to large numbers, stored and infused into patients. Currently these procedures are done in individual laboratories leading to duplication of efforts and raising concerns about reproducibility and quality control. We request matching funds for the construction of a cGMP Cellular Therapy shared resource facility that will permit reproducible production of large quantities of human hematopoietic or immunocompetent cells under the stringent quality conditions that are essential for use in human studies. The Center will provide the necessary ancillary services including cryopreservation and flow cytometry to allow these studies to proceed. This will result in better resource utilization and better quality control of manipulated cell populations for our human studies as required by FDA regulations.